Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs— 510(k) K161154
Substantially EquivalentSpr Therapeutics, LLC
FDA 510(k) clearance K161154 for Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs, Substantially Equivalent on 2016-07-23. Applicant: Spr Therapeutics, LLC.
Clearance details
- Applicant
- Spr Therapeutics, LLC
- Product code
- Code NHI
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.